(WAVE) – Mirtazapine, a medication used to treat major depressive disorder, is recalled due to its strength being labeled wrong on the packaging, as reported by the FDA.
One lot of the medication with the number 03119002A3 has an error on bottles labeled as Mirtazapine 7.5 mg, but the bottles could potentially contain 15 mg tablets.
Mirtazapine is produced by Aurobindo Pharma USA, Inc. and is packaged in 500-count bottles.
The FDA recall announcement states, “Taking a higher dose than expected, may increase risk of sedation, agitation, increased reflexes, tremor, sweating, dilated pupils, gastrointestinal distress, nausea, constipation and more. Unexpected levels of sedation in particular can contribute to falls in the elderly or motor vehicle accidents in adults."
The announcement from the FDA reveals Aurobindo Pharma USA, Inc. is contacting distributors of Mirtazapine by letter and is requesting returns of the recalled medications and packaging.
The FDA urges retailers with the recalled products to return them to the place of purchase.
Patients with problems or concerns about the medication or recall should call their doctor.
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